Trial Outcomes & Findings for Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease (NCT NCT00946530)
NCT ID: NCT00946530
Last Updated: 2018-10-03
Results Overview
The amount of actual sleep time in a sleep episode.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
2 weeks
Results posted on
2018-10-03
Participant Flow
Participants were recruited from the local community, from 2004-2008
diagnosis changed for 2 care-recipients, so 2 dyads were not included in the final analysis.
Participant milestones
| Measure |
Bright Light - AD Patient
AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
|
Dim Light (Control) - AD Patients
AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
|
Bright Light - Caregiver
Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
|
Dim Light (Control) - Caregiver
Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
27
|
32
|
27
|
|
Overall Study
COMPLETED
|
31
|
23
|
31
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
1
|
4
|
Reasons for withdrawal
| Measure |
Bright Light - AD Patient
AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
|
Dim Light (Control) - AD Patients
AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
|
Bright Light - Caregiver
Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
|
Dim Light (Control) - Caregiver
Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
3
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
1
|
Baseline Characteristics
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Bright Light-AD Patients
n=31 Participants
AD patients received bright light
|
Dim Light (Control) - AD Patients
n=23 Participants
AD patients received dim light in the Control condition
|
Bright Light - Caregivers
n=31 Participants
Caregivers received bright light
|
Dim Light (Control) - Caregivers
n=23 Participants
Caregivers received dim light in the Control condition
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
23 participants
n=7 Participants
|
31 participants
n=5 Participants
|
23 participants
n=4 Participants
|
108 participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: dyads consisting of 1 AD patient and 1 caregiver
The amount of actual sleep time in a sleep episode.
Outcome measures
| Measure |
Bright Light - AD Patient
n=31 Participants
AD patient received bright light
|
Dim Light (Control) - AD Patients
n=23 Participants
AD patient received regular (dim) light
|
Bright Light - Caregiver
n=31 Participants
Caregiver received Bright Light
|
Dim Light (Control) - Caregiver
n=23 Participants
Caregiver received regular (dim) Light
|
|---|---|---|---|---|
|
Total Sleep Time
|
393 units on a scale (minutes)
Standard Deviation 127
|
420 units on a scale (minutes)
Standard Deviation 125
|
398 units on a scale (minutes)
Standard Deviation 65.4
|
409 units on a scale (minutes)
Standard Deviation 84.9
|
SECONDARY outcome
Timeframe: 2 weeksWASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good.
Outcome measures
| Measure |
Bright Light - AD Patient
n=31 Participants
AD patient received bright light
|
Dim Light (Control) - AD Patients
n=23 Participants
AD patient received regular (dim) light
|
Bright Light - Caregiver
n=31 Participants
Caregiver received Bright Light
|
Dim Light (Control) - Caregiver
n=23 Participants
Caregiver received regular (dim) Light
|
|---|---|---|---|---|
|
WASO (Wake After Sleep Onset)
|
124 units on a scale (minutes)
Standard Deviation 111
|
107 units on a scale (minutes)
Standard Deviation 110
|
63.4 units on a scale (minutes)
Standard Deviation 60.0
|
61.0 units on a scale (minutes)
Standard Deviation 64.8
|
Adverse Events
Bright Light-AD Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dim Light (Control) - AD Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bright Light - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dim Light (Control) - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place